510(k) K250199 ยท QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
VitalFlow Console
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, May 20, 2025 |
| Received | Jan 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250199
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2025 | Medtronic Perfusion Systems MC3 VitalFlow Console, REF 58100; Blood pump of ecmo Open, Classified |
QNR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.